FDA Adverse Event
Malfunction
Summary report: N
ESOPHYX 2-LINK
MDR report key: 2940983
·
Received January 23, 2013
Report
- Report Number
- 2940983
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 23, 2013
- Manufacturer
- ENDOGASTRIC SOLUTIONS, INC.
- Product Code
- ODE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
SURGEON WAS ATTEMPTING TO PULL THE STYLET OUT ON THE ESOPHYX DEVICE. THEY BELIEVE THE DEVICE WAS NOT LINED UP PROPERLY AND WHEN THE STYLET CAME OUT, IT HIT TISSUE MOLD AND BENT THE SPRING COIL ON THE DEVICE MAKING ONE CHAMBER USELESS. WE WERE ABLE TO USE THE ONE GOOD CHAMBER OF THE DEVICE WITH NO INJURY TO THE PATIENT. THE REPRESENTATIVE FROM THE COMPANY WANTED THE DEVICE BACK SO HIS COMPANY COULD LOOK AT IT TO MAKE SURE IT WAS USER ERROR OR IF IT WAS THE DEVICE ITSELF.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROCEDURE PERFORMED:1. LAPAROSCOPIC HIATAL HERNIA REPAIR.2. TRANSORAL FUNDOPLICATION WITH ESOPHYX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32743 | ESOPHYX 2-LINK | TRANSORAL FUNDOPLICATION SYSTEM | ODE | ENDOGASTRIC SOLUTIONS, INC. | * | 401416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |